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The LAGUNA® Polyaxial Pedicle Screw System is intended for posterior, non-cervical fixation for the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis; trauma (i.e. fracture or dislocation), spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

The LAGUNA® Polyaxial Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case Multi axial screws are supplied in winged and non-winged configurations, in a variety of different length, and in 5mm, 6mm, and 7mm diameter sizes All sizes are able to receive 5 5mm connecting rods only. The LAGUNA® Polyaxial Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.

This document describes the Allez Spine Laguna Polyaxial Pedicle Screw System, a spinal fixation system. However, the provided text does not contain acceptance criteria for specific performance metrics (like accuracy, sensitivity, or specificity) or detailed study results directly proving the device meets certain quantitative acceptance criteria in the way an AI/ML device submission would.

Instead, the submission focuses on substantial equivalence to a previously marketed predicate device and mentions general biomechanical tests.

Therefore, I cannot generate a table of acceptance criteria and reported device performance or answer most of the specific questions about clinical study design, as this information is not present in the provided 510(k) summary and FDA letter.

I can, however, extract what is mentioned regarding performance and study type:

Performance Data Mentioned:

• "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading."

This statement indicates that the device underwent non-clinical performance testing (biomechanical tests) to demonstrate its mechanical properties and safety for its intended use. The acceptance criteria for these tests would typically involve meeting specific strength, fatigue, and other mechanical property thresholds established for similar spinal fixation devices. The specific thresholds are not provided in this summary.

Given the nature of the device (a physical medical implant, not an AI/ML diagnostic or predictive tool), the questions related to sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable as they pertain to clinical or AI/ML performance evaluation studies.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable / Not Provided. The document refers to biomechanical tests, not a clinical test set in the context of diagnostic accuracy. Biomechanical tests typically involve a defined number of device units tested under specific conditions to assess mechanical properties. The specific 'sample size' (number of units tested) is not provided, nor is the data provenance in this context applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable / Not Provided. This type of information is relevant for clinical studies involving expert interpretation, which is not described here for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable / Not Provided. This is relevant for clinical studies with expert reviewers, not for biomechanical performance testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is a physical implant device, not an AI-based diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a physical implant device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the biomechanical tests, the "ground truth" would be the engineering standards and specifications (e.g., ASTM F1717 for static and fatigue testing of spinal implant constructs, or similar standards relevant to pedicle screw systems) that define acceptable mechanical performance. The device's performance is measured against these established engineering standards.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not Applicable. As above, it's not an AI/ML algorithm.

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